Ponemah SEND Module

Automatically convert your data to a SEND domain format.

The Standard for Exchange of Non-clinical Data (SEND) is a data formatting standard required for certain Safety Pharmacology, General Toxicology and Reproductive Toxicology studies for submission to the FDA.  The Ponemah SEND Module provides a simple method for converting your Ponemah data to a SEND 3.1-compliant format. 

SEND Viewer
Spend Less Time on Formatting and More Time on the Science
  • Easily convert your Data Reduction time points to a SEND-compliant output with a few mouse clicks
  • Supports the following SEND domains:
    • ECG Test Results – EG
    • Cardiovascular Test Results – CV
    • Respiratory Test Results – RE
    • Vital Signs - VS
  • Integrates with Study Protocol Option to reduce manual data entry
Easy Integration with SEND Package Compilation and Submission Solutions
  • Compatible with major LIM Systems and SEND submission software, including:
    • Instem Provantis™ and submit™
    • Xybion Pristima™
  • Excel output and SQL database support available
DSI is Here to Help
  • To help ensure your success with SEND, DSI has partnered with Instem, the leading global provider of SEND solutions.
    • Instem’s SEND experts can help organize, educate and guide you to becoming SEND-Ready and their Safety Pharmacology configuration package in particular can maximize the benefits of SEND while ensuring regulatory compliance.
    • You can begin leveraging Instem’s full array of expertise with a SENDReady™ Analysis and/or a practical introduction to SEND through one of their popular training courses.
    • Instem’s submit™-for-SEND software suite and their outsourced study services have been adopted at over 85 sites across 15 countries.
    • Through the power of our partnership with Instem, DSI can now meet you at any stage of SEND Readiness to fully support you from system set-up to SEND submission.”

Compatibility

The Ponemah SEND Module, compliant to SEND 3.1, is compatible with:

  • Ponemah v5.30 and later


Contact DSI Client Services or your DSI Account Manager for more information on the Ponemah SEND Module.